New clinical trial for Covid-19 vaccine approved

Anvisa published Tuesday, July 21, the approval to conduct a clinical trial that will study two types of vaccines for Covid-19: BNT162b1 and BNT162b2, which are being developed by the companies BioNTech and Pfizer (Wyeth).  

The vaccines are based on ribonucleic acid (RNA), which encodes a specific antigen of the Sars-CoV-2 virus. RNA is translated by the human body into proteins that induce immune response. About 29,000 volunteers are expected to take part in the study, 1,000 of them in Brazil, specifically in the states of São Paulo and Bahia. The centers conducting the research are responsible for recruiting volunteers. 

The approved clinical trial is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in adults. The study will evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-CoV-2 RNA vaccine candidates against COVID-19. The clinical trial consists of three stages and Brazil will participate in stage 3.  

Authorization  

To authorize the trial, Anvisa analyzed data from previous stages of the product development, including non-clinical in vitro and animal studies, as well as data from ongoing clinical trials. The results so far have demonstrated acceptable safety regarding the potential vaccines. 

This is the third Covid-19 vaccine study authorized by Anvisa in Brazil. On June 2 the Agency authorized the clinical trial of the vaccine developed by the University of Oxford, and on July 3 the vaccine developed by Sinovac Biotech Ltd., in partnership with Butantan Institute.  

Analysis priorities 

For the approval of the new clinical trial, Anvisa together with Pfizer and BioNTech had to align all the technical requirements for the tests. 

Since the start of the public calamity in Brazil due to the coronavirus pandemic, the Agency has adopted strategies to speed up the analysis and decisions on any demand aiming to fight Covid-19. 

One of these strategies was the creation of an evaluation committee for clinical trials, registration and post-registration changes of drugs for the prevention or treatment of the disease. The group also acts to reduce the risk of drug shortages, which may impact public health.  

Clinical Trials

Clinical trials are research studies of a new drug with tests in humans. Clinical tests are important to validate the efficacy and safety of a drug or its new therapeutic indications. 

The start of tests in humans depends on two factors: the approval by the Brazilian Research Ethics Committee (Conep), a collegiate board within the Ministry of Health responsible for the ethical evaluation of clinical research, and the researchers' own organization for recruiting volunteers. Anvisa does not set any date on this matter.